Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
  • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
  • A61L15/42—Use of materials characterised by their function or physical properties
  • A61L15/46—Deodorants or malodour counteractants, e.g. to inhibit the formation of ammonia or bacteria
• • A—HUMAN NECESSITIES
  • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
  • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
  • A01N47/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom not being member of a ring and having no bond to a carbon or hydrogen atom, e.g. derivatives of carbonic acid
  • A01N47/40—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom not being member of a ring and having no bond to a carbon or hydrogen atom, e.g. derivatives of carbonic acid the carbon atom having a double or triple bond to nitrogen, e.g. cyanates, cyanamides
  • A01N47/42—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom not being member of a ring and having no bond to a carbon or hydrogen atom, e.g. derivatives of carbonic acid the carbon atom having a double or triple bond to nitrogen, e.g. cyanates, cyanamides containing —N=CX2 groups, e.g. isothiourea
  • A01N47/44—Guanidine; Derivatives thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/74—Synthetic polymeric materials
  • A61K31/765—Polymers containing oxygen
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
  • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
  • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
  • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
  • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
  • A61L2300/204—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
  • A61L2300/206—Biguanides, e.g. chlorohexidine
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
  • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
  • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents

Definitions

• the invention relates to a lactate-free pure Ringer's solution with additives which make it suitable for decontaminating wounds to a germ-free or saprophytic state and for maintaining such a state during the entire healing period.
• wound treatment agents are known, but they are used for medicinal use because of their poor tissue tolerance, their high protein errors (impairment of bactericidal activity in the presence of protein, e.g. wound secretions and blood, their partially inadequate bactericidal activity and because of their disadvantageous nature Properties of being absorbed by the body in more or less large quantities are unsuitable or unsatisfactory.
• tissue compatibility of such agents is sometimes not sufficient due to excessive surface tension.
• iodophores When iodophores are used for wound treatment, the absorption of iodine and thus the risk of iodine-related disorders must be expected. Furthermore, iodophores have a considerable protein defect. An iodophor dilution of 1:10 shows a good bactericidal activity in the laboratory test, but this is almost completely or largely eliminated in the presence of 20% whole blood. Because of the risk of postoperative shock even with fatal outcome, the intra-abdominal use of iodophores has been completely abandoned.
• Chlorhexidine is essentially only bacteriostatic and is therefore no longer recommended for local wound treatment.
• the object of the invention is therefore to provide an aqueous solution which has a particularly high bactericidal activity with a largely low protein error, but is practically not absorbed by the body even in contact with open wounds even after prolonged use for several weeks.
• the solution should therefore above all be usable as a bactericidal medication for local wound treatments and reduce or completely eliminate the use of additional systemic antibiotics.
• This requires good tissue wettability and a high tissue tolerance of the solution according to the invention which is comparable to Ringer's solution.
• the solution is also said to be free of heavy metals, iodine, PVP and aldehydes and is intended to rapidly reduce the general effects of inflammation (fever, toxic symptoms) without the need for additional antibiotics.
• a lactate-free, pure Ringer's solution which additionally contains 0.1% of a concentrate, which consists of a 20% aqueous polyhexamethylene biguanidine hydrochloride solution in which per 100 ml lg of polyethylene glycol with a molecular weight of about 4,000.
• a process for the preparation of polyhexamethylene biguanidine hydrochloride is known from German patent 16 20 938. It has the general formula: and is under the trade name "Vantocil IB" from Imperial Chemical Industries Ltd. for a surface infection agent in the food, brewery and beverage industry on the market.
• the polyethylene glycol in question is available on the market under the trade name "LUTROL E 4000" from BASF.
• the solution according to the invention has a high bactericidal activity which is highly effective against all medically important bacteria and fungi.
• the solution according to the invention has no protein error in the presence of 2% albumin and only a very small protein error in the presence of 20% whole blood.
• the solution according to the invention is not a conventional disinfectant, e.g. for hand disinfection must have reached its full effectiveness within a short time of 30 s to a maximum of 1 min.
• the solution according to the invention is unsuitable as a skin disinfectant, in particular for the preparation of surgical interventions.
• the action time of the solution according to the invention on the pathogenic germs in infected wounds is at least 20 to 60 min. Even with wound treatment for weeks with the solution according to the invention, there is no decreasing tendency in the high tolerance. No noteworthy absorption of the solution according to the invention was also found. Only when the concentration of 0.2% according to the invention is exceeded can wound healing disorders be expected. Experiments with a 0.4% solution showed that it is no longer suitable as a bactericidal medication due to incompatibility.
• concentration of 0.1% according to the invention is completely sufficient for normal use. Only in exceptional cases, especially with spec. Gram-negative germs, as they occur especially in the oral cavity, an increased concentration of the biguanide used according to the invention of 0.2% is recommended, which, however, must not be exceeded. Concentrations significantly below 0.1% do not show sufficient bactericidal activity even after prolonged exposure to infected wounds.
• the medicinal character of the solution according to the invention in contrast to conventional disinfectants, is particularly clear, since the solution according to the invention, as a long-term treatment agent, initially ensures rapid and adequate decontamination of the infected wounds except for a saprophytic germ state and this also during the entire healing period with constant or interval use maintained. Accordingly, the solution according to the invention acts as a prophylactic agent for protecting wounds from additional contamination during the entire healing process.
• Wound irrigation of acute and chronic bone and soft tissue infections Flushing cookers as preparation for clearing the cooker; Rinsing of debrided herds in order to be able to carry out the definitive surgical healing measures in an optimally decontaminated environment, such as the insertion of free bone grafts (cancellous bone), but also pedicled soft tissue and bone grafts; Wound irrigation during the operation, in particular also to combat the body's own germs, which can become pathogenic after being released in the operating area (hospitalism); to cover wounds left open postoperatively, for example with longettes, which are soaked with the solution according to the invention; Rinsing and the use of tamponades impregnated with the solution according to the invention in dental surgery; Peroperative rinsing for operations at risk of infection such as osteosynthesis, when inserting and changing endoprostheses, for wound care, for abdominal wall wounds after the peritoneum has been closed.
• an optimally decontaminated environment such as the insertion of free bone grafts (cancellous
• the 0.1% solution according to the invention has also proven effective in intra-abdominal irrigation, namely preventively after gastric and intestinal resections and therapeutically after cholecystectomy for cholecysisitis actua. Peritonic complications (residual abscesses) were never observed.
• the flush volume should not exceed 1000 ml and the flush duration should not exceed 15 to 20 minutes. Then you should rinse with Ringer's solution. Absorption was also not demonstrated in intra-abdominal irrigation with a limited irrigation volume. In exceptional cases, such an application can also be carried out with a 0.2% solution according to the invention.
• the intra-abdominal application of the solution according to the invention therefore has significant advantages over iodophores, which are increasingly avoided for this purpose because of iodine-related disorders.
• the drip instillation with Ringer's solution is interrupted 1 to 3 times and a drip instillation with the solution according to the invention is interposed.
• cancellous bone forms a particularly favorable criterion to show the advantageous influence of the solution according to the invention on the demanding process of healing cancellous bone.
• the cancellous bone insoles could be completely healed quantitatively.
• the consistently safe healing of the cancellous bone both in the host bed and in the context of an open wound treatment can be seen as an important indication that covering the wounds with gauzes soaked in a solution according to the invention is an optimal one for wound healing
• the degree of decontamination is not only reached, but can also be maintained over a long period of time.
• the bacteriological swabs of the wounds left open postoperatively showed a good agreement with the clinically suspected degree of decontamination.
• the first postoperative swab swabs or the content of suction drainage were germ-free; in the "cortex" cases it was 4/5.
• treatment with the solution according to the invention caused the following pathogens to disappear after different exposure times: Staph. aureus various streptococci (enterococci) Clostridium sphenoides Pseudomonas aeruginosa Serratus marcescens Staph. epidermidis E. Coli Proteus morganii u. vulgaris Klebsiella Aeromonas hydrophilia anaerobic corynebacteria Achromobacter agglomerans
• the solution according to the invention thus represents an effective antiseptic in the sense of a bactericidal and tissue-friendly adjuvant for wound treatment, particularly in the surgical treatment of acute and chronic bone and soft tissue infections, with good treatment successes being achievable in many cases even without administration of systemic antibiotics.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• General Health & Medical Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Engineering & Computer Science (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• Animal Behavior & Ethology (AREA)
• Epidemiology (AREA)
• Medicinal Chemistry (AREA)
• Pharmacology & Pharmacy (AREA)
• Plant Pathology (AREA)
• Dentistry (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Hematology (AREA)
• Materials Engineering (AREA)
• Agronomy & Crop Science (AREA)
• General Chemical & Material Sciences (AREA)
• Oil, Petroleum & Natural Gas (AREA)
• Pest Control & Pesticides (AREA)
• Wood Science & Technology (AREA)
• Zoology (AREA)
• Environmental Sciences (AREA)
• Medicinal Preparation (AREA)
• Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Priority Applications (2)

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Publications (1)

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Cited By (15)

Citations (2)

• 1990
  • 1990-04-02 EP EP90106312A patent/EP0450117A1/fr not_active Ceased
• 1991
  • 1991-03-28 CA CA 2039457 patent/CA2039457A1/fr not_active Abandoned

Patent Citations (2)

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